dc.creator | Abrisqueta, Pau | es |
dc.creator | Loscertales, Javier | es |
dc.creator | Terol, María José | es |
dc.creator | Ramírez Payer, Ángel | es |
dc.creator | Ortiz, Macarena | es |
dc.creator | Pérez, Inmaculada | es |
dc.creator | Ríos Herranz, Eduardo | es |
dc.creator | Villanueva, Miguel | es |
dc.date.accessioned | 2023-09-28T12:27:51Z | |
dc.date.available | 2023-09-28T12:27:51Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Abrisqueta, P., Loscertales, J., Terol, M.J., Ramírez Payer, Á., Ortiz, M., Pérez, I.,...,Villanueva, M. (2021). Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study). Clinical Lymphoma, Myeloma and Leukemia, 21 (12), e985-e999. https://doi.org/10.1016/j.clml.2021.07.022. | |
dc.identifier.issn | 2152-2650 | es |
dc.identifier.issn | 2152-2669 | es |
dc.identifier.uri | https://hdl.handle.net/11441/149210 | |
dc.description.abstract | Ibrutinib demonstrated robust efficacy, regardless of high-risk features, in previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). The IBRORS-CLL study supports the effectiveness and the manageable safety profile of single-agent ibrutinib, which was not adversely affected by high-risk characteristics in real-world CLL patients in Spain. We also found a high molecular testing rate of del(17p)/TP53
mutation and IGHV mutation status.
Background: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibruti-nib in routine clinical practice in Spain.Patients: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019. Results: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated
IGHV. Common grade ≥3 adverse events were infections (12.2%) and bleeding (3%). Grade ≥3 AF occurred in 1.5% of patients. Conclusion: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations. | es |
dc.description.sponsorship | Janssen-Cilag S.A | es |
dc.format | application/pdf | es |
dc.format.extent | 15 | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | Clinical Lymphoma, Myeloma and Leukemia, 21 (12), e985-e999. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Chronic lymphocytic leukemia (CLL) | es |
dc.subject | Ibrutinib | es |
dc.subject | Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) | es |
dc.title | Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study) | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.identifier.doi | 10.1016/j.clml.2021.07.022 | es |
dc.journaltitle | Clinical Lymphoma, Myeloma and Leukemia | es |
dc.publication.volumen | 21 | es |
dc.publication.issue | 12 | es |
dc.publication.initialPage | e985 | es |
dc.publication.endPage | e999 | es |